This report is for an unknown cable/wire/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, patient underwent a femur open reduction internal fixation (orif) a vancouver b2 fracture in (b)(6) 2010.The patient was implanted with a lcp 4/55.0 15 hole board curved plate.The duration of follow-up was six (6) month and the healing status/result at final follow-up was healed.The patient has presented a second time with a new fracture line which healed (b)(6) 2012, post revision orif.No further information available.Concomitant devices reported: plates: 3.5 mm lcp hook plate (part number unknown, lot unknown, quantity 1), screws: trauma (part number unknown, lot unknown, quantity 1).This report involves one (1) unknown cable/wire.This is report 3 of 3 for (b)(4).
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